A Clinical Trial to Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Compare the maximum plasma concentration (Cmax)
研究概览
简要总结
This phase 1 clinical trial is to evaluate the effects of the environmental change in intestine by antibiotics on the pharmacokinetic characteristics of simvastatin in healthy male volunteers. For change of intestine environment, especially the gut microbiota, investigators will administer PO vancomycin for 7 days, tid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 19 Y to 50 Y at the screening
- •Body weight over 55 kg and BMI should be between 18.0 to 25.0 kg/m2
- •Informed consent will be taken before all the procedures from volunteers
- •SLCO1B1 genotype is *1/*1 when screening
排除标准
- •No significant disease history or ongoing disease
- •Allergic to simvastatin and vancomycin, or similar affiliation drug for simvastatin or vancomycin
- •MDRD eGFR less than 60 mL/min/1.73m2
- •Total cholesterol, LDL, TG is higher than 1.5 times more than upper normal limit at the screening
- •HDL less than 35 mg/dL at the screening
- •Positive HBV or HIV or HCV
- •Who is administering or going to administer CYP3A4 inihibitor drug
- •Other clinically significant situation under doctor's opinion
研究组 & 干预措施
Group
Intervention: vancomycin 500 mg tid for 7 days (Vancozin 250 mg capsule)
干预措施: Vancomycin 250Mg Capsule (Drug)
结局指标
主要结局
Compare the maximum plasma concentration (Cmax)
时间窗: vancomycin PO will administered for 7 days
Compare the maximum plasma concentration (Cmax) of simvastatin before and after vancomycin PO treatment.
Compare the area under the time-plasma concentration curve (AUC)
时间窗: vancomycin PO will administered for 7 days
Compare the area under the time-plasma concentration curve (AUC) of simvastatin before and after vancomycin PO treatment.
次要结局
- Explore the gut microbiome species change(vancomycin PO will administered for 7 days)
研究者
SeungHwan Lee
Clinical Assistant Professor
Seoul National University Hospital